Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201808524461224 Date of Approval: 23/08/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title INTEGRATION OF CARDIOVASCULAR DISEASE SCREENING AND PREVENTION IN THE HIV MANAGEMENT PLAN FOR WOMEN OF REPRODUCTIVE AGE IN A RESOURCE-LIMITED SETTING
Official scientific title INTEGRATION OF CARDIOVASCULAR DISEASE SCREENING AND PREVENTION IN THE HIV MANAGEMENT PLAN FOR WOMEN OF REPRODUCTIVE AGE IN A RESOURCE-LIMITED SETTING
Brief summary describing the background and objectives of the trial Worldwide, the leading cause of death is from cardiovascular disease (CVD) with the majority of deaths occurring in developing countries. There is growing evidence of HIV-related chronic inflammation, immune activation and certain antiretroviral drugs that contribute to the increased presence of metabolic syndrome and potential early onset CVD in people living with HIV. A recent recommendation by the World Health Organization (WHO) is the provision of a cardiovascular risk assessment in all people living with HIV (PLWH) using standard protocols recommended for the general population. The commonly used cardiovascular risk assessment tools are non-specific to HIV and/or resource-constrained settings. Young HIV positive women are faced with the highest incidence of HIV in Africa. The overarching aim of the study is to determine the impact of including screening for prognostic markers of cardiovascular disease on the modification of cardiovascular risk factors in HIV positive women of reproductive age.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) The ISCHeMiA study
Disease(s) or condition(s) being studied Cardiology,Circulatory System,Infections and Infestations,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/08/2018
Actual trial start date
Anticipated date of last follow up 01/08/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group No active intervention 3 years follow-up Standard of care HIV management and primary health care will be provided by public sector clinic staff according to current national guidelines at a primary health care facility separate to the research clinic. No study investigations or study questionnaires will be carried out at entry visit until the final study visit. There will be regular telephonic follow up with the participants to maintain study retention. Data collection from clinic medical chart review will be conducted at 6 monthly intervals. CVD risk factors will be measured by the study at a single 3 year final study visit. Information obtained will be conveyed to the clinic staff for further management if required. 200 Historical
Experimental Group Behavioural and medical treatment of identifiable risk factors for cardiovascular disease NA 3 years Located at the research clinic.The prevalence of CVD risk factors will be determined by data collection through history taking, physical examination, and laboratory and radiology investigations. CVD risk assessment will be performed annually using a combination of the WHO and International Society of Hypertension cardiovascular risk prediction (WHO/ISH) and the DAD CHD equation. The intervention proposed is a modified WHO PEN algorithm incorporated into HIV management guidelines from study entry. Intervention includes screening for cardiovascular disease risk and prompt treatment of identifiable risk factors through structured lifestyle modification advice and medical management. Trends in all risk factors will be monitored, and new risk factors identified, with 6 monthly intervention during the first year, and annually for three years thereafter. 200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• HIV infected women • On ART for at least 1 year • Equal to/older than 18 years of age • Equal to/younger than 49 years of age • Plans to remain in the study catchment area for at least 3 years • Participant declines study participation Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 49 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/07/2018 Biomedical Research Ethics Commitee
Ethics Committee Address
Street address City Postal code Country
Westville Campus, Govan Mbeki Buidling, Private Bag X54001 Durban 4000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of Women in the Intervention group with Post-intervention Modification of risk factors: Obesity (BMI, Waist circumference), Dyslipidaemia (Fasting lipid profile), Hypertension (Systolic BP), Diabetes (glycosuria, fasting glucose), Microalbuminuria (urine albumin), Elevated hsCRP. Presence of atherosclerosis detected by carotid intima media thickness. Annually for 3 years for all primary outcomes excluding carotid intima media thickness measured at final study 3 year visit
Secondary Outcome Calculated cardiovascular risk as per WHO –ISH, DAD and Framingham compared to short term outcomes (presence of subclinical atherosclerosis by means of CMIT, presence of stroke, MI, angina -ischaemic heart disease) Annually for 3 years for all seconadry outcomes excluding carotid intima media thickness measured at final study 3 year visit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CAPRISA Umlazi research clinic Philasande Clinic Prince Mshiyeni Memorial Hospital 1358 Mangosuthu Highway Durban 4066 South Africa
Gateway Umlazi PHC 1358 Mangosuthu Highway Durban 4066 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
UKZN Developing Research Innovation Localization and Leadership in South Africa DRILL Howard College campus Gate 3 Rick Turner Road Durban 4000 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UKZN DRILL NIH Fogarty International Centre D43 grant Howard college campus Gate 3 Rick Turner Road durban 4000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherika Hanley hanley@ukzn.ac.za +27312602731 1358 Mangosuthu Highway
City Postal code Country Position/Affiliation
Durban 4066 South Africa Principal Investigator DRILL fellow
Role Name Email Phone Street address
Public Enquiries Sherika Hanley hanley@ukzn.ac.za +27312602731 1358 Mangosuthu Highway
City Postal code Country Position/Affiliation
Durban 4066 South Africa Principal Investigator DRILL fellow
Role Name Email Phone Street address
Scientific Enquiries Sherika Hanley hanley@ukzn.ac.za +27312602731 1358 Mangosuthu Highway
City Postal code Country Position/Affiliation
Durban 4066 South Africa Principal Investigator DRILL fellow
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information